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News  ›  GlobeNewswire Inc.

Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms

GlobeNewswire Inc. Logo GlobeNewswire Inc. • •By Cytokinetics, Incorporated
Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms

Cytokinetics announced FDA approval of MYQORZO (aficamten), a cardiac myosin inhibitor for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval is based on the SEQUOIA-HCM Phase 3 trial, which demonstrated significant improvements in exercise capacity and symptom relief. The drug will be available in the U.S. in the second half of January 2026 and is subject to a REMS program due to heart failure risks. Cytokinetics also received NMPA approval in China and a positive opinion from the European Medicines Agency.

Insights
BMLpJ   positive

Maintains Buy rating and sees promising growth potential for Medtronic's medical technologies

CYTK   positive

Company achieved its first FDA approval for MYQORZO, a significant milestone. The drug demonstrated robust efficacy in clinical trials with meaningful improvements in exercise capacity and symptom relief. Additional regulatory approvals in China and positive opinion from EMA provide further validation and expansion opportunities. The approval represents a major achievement for the company's pipeline and future revenue potential.

Keywords
#FDA approval #MYQORZO #aficamten #cardiac myosin inhibitor #obstructive hypertrophic cardiomyopathy #oHCM #SEQUOIA-HCM trial #heart failure risk #REMS program #China NMPA approval #European Medicines Agency

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CYTK SNY
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